Electrical stimulation device having multiple stimulation channels

ABSTRACT

An implantable electrical stimulation device configured to treat multiple pelvic conditions of a patient includes a pulse generator, memory, first and second electrode leads comprising one or more electrodes, a switch and a controller. The switch has a first state, in which the first electrode lead is electrically coupled to the pulse generator, and a second state, in which the second electrode lead is electrically coupled to the pulse generator. The controller includes at least one processor that is configured to execute at least one stimulation program stored in the memory. The controller is also configured to selectively set the switch in the first or second state. Electrical stimulation pulses generated by the pulse generator responsive to the execution of the stimulation program are delivered to the first or second electrode lead depending on the state of the switch.

BACKGROUND

Electrical stimulation devices have been used to deliver electricalstimulation therapies for the purpose of treating a variety of pelvicconditions such as urinary and fecal incontinence. A typical electricalstimulation system includes one or more implantable medical leadscoupled to an external or implantable electrical stimulator device. Theimplantable lead may be percutaneously or surgically implanted in apatient on a temporary or permanent basis such that an electrode ispositioned at a single target stimulation site. Electrical pulses can begenerated by the device and delivered to the target stimulation sitethrough the electrode to perform the electrical stimulation therapy andtreat the condition of the patient. For instance, urinary incontinencecan be treated through electrical stimulation of the urinary sphincter.Likewise, fecal incontinence can be treated through electricalstimulation of the anal sphincter.

Some patients have both urinary incontinence and fecal incontinence, orinitially have one of the conditions and then later develop the other.Conventional electrical stimulation devices are only configured to applyelectrical stimulation therapies to a single targeted site (e.g.,urinary sphincter or anal sphincter) to treat the associated condition.Thus, patients requiring treatment for both urinary incontinence andfecal incontinence require a stimulation device for each of theconditions in order to deliver two separate electrical stimulationtherapies to treat the conditions.

SUMMARY

Embodiments of the invention are directed to an implantable electricalstimulation device that is configured to treat multiple pelvicconditions of a patient and methods of using the device to treatmultiple pelvic conditions of a patient. One embodiment of the deviceincludes a pulse generator (106), memory (104), first and secondelectrode leads (110, 112) comprising one or more electrodes (114), aswitch (124) and a controller (102). The switch has a first state, inwhich the first electrode lead is electrically coupled to the pulsegenerator, and a second state, in which the second electrode lead iselectrically coupled to the pulse generator. The controller includes atleast one processor that is configured to execute at least onestimulation program (120, 122) stored in the memory. The controller isalso configured to selectively set the switch in the first or secondstate. Electrical stimulation pulses generated by the pulse generatorresponsive to the execution of the stimulation program are delivered tothe first or second electrode lead depending on the state of the switch.

Another embodiment of the implantable electrical stimulation devicecomprises first and second pulse generators (106A, 106B), memory (104)and a controller (102). The controller includes at least one processorthat is configured to execute at least one stimulation program (120,122) stored in the memory. The first and second pulse generators areeach configured to produce stimulation pulses responsive to theexecution of the at least one stimulation program.

In one embodiment of the method, an electrical stimulation device (100)comprising a control unit (101) and first and second electrode leads(110, 112) is implanted (130) in a patient. In one embodiment, the firstelectrode lead comprises one or more electrodes (114) positioned at afirst stimulation site (116), and the second electrode lead comprisesone or more electrodes (114) positioned at a second stimulation site(118) that is different from the first stimulation site. A firststimulation treatment is performed (132) that comprises deliveringelectrical stimulation signals to the first stimulation site through thefirst electrode lead. A first pelvic condition of a patient is treated(134) responsive to the first stimulation treatment. A secondstimulation treatment is also performed (136) comprising deliveringelectrical stimulation signals to the second stimulation site throughthe second electrode lead. A second pelvic condition of the patient istreated (138) responsive to the second stimulation treatment.

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not indented to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. The claimed subject matter is not limited to implementationsthat solve any or all disadvantages noted in the Background.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are simplified block diagrams of electrical stimulationdevices formed in accordance with embodiments of the invention.

FIG. 3 is a flowchart illustrating a method of treating multiple pelvicconditions of a patient in accordance with embodiments of the invention.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Embodiments of the invention are described more fully hereinafter withreference to the accompanying drawings. The various embodiments of theinvention may, however, be embodied in many different forms and shouldnot be construed as limited to the embodiments set forth herein. Rather,these embodiments are provided so that this disclosure will be thoroughand complete, and will fully convey the scope of the invention to thoseskilled in the art. Elements that are identified using the same orsimilar reference characters refer to the same or similar elements.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

It will be understood that when an element is referred to as being“connected” or “coupled” to another element, it can be directlyconnected or coupled to the other element or intervening elements may bepresent. In contrast, if an element is referred to as being “directlyconnected” or “directly coupled” to another element, there are nointervening elements present.

It will be understood that, although the terms first, second, etc. maybe used herein to describe various elements, these elements should notbe limited by these terms. These terms are only used to distinguish oneelement from another. Thus, a first element could be termed a secondelement without departing from the teachings of the present invention.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

As will further be appreciated by one of skill in the art, the presentinvention may be embodied as methods, systems, and/or computer programproducts. Accordingly, the present invention may take the form of anentirely hardware embodiment, an entirely software embodiment or anembodiment combining software and hardware aspects. Furthermore, thepresent invention may take the form of a computer program product on acomputer-usable storage medium having computer-usable program codeembodied in the medium. Any suitable computer readable medium may beutilized including hard disks, CD-ROMs, optical storage devices, ormagnetic storage devices.

The computer-usable or computer-readable medium may be, for example butnot limited to, an electronic, magnetic, optical, electromagnetic,infrared, or semiconductor system, apparatus, device, or propagationmedium. More specific examples (a non-exhaustive list) of thecomputer-readable medium would include the following: an electricalconnection having one or more wires, a portable computer diskette, arandom access memory (RAM), a read-only memory (ROM), an erasableprogrammable read-only memory (EPROM or Flash memory), an optical fiber,and a portable compact disc read-only memory (CD-ROM). Note that thecomputer-usable or computer-readable medium could even be paper oranother suitable medium upon which the program is printed, as theprogram can be electronically captured, via, for instance, opticalscanning of the paper or other medium, then compiled, interpreted, orotherwise processed in a suitable manner, if necessary, and then storedin a computer memory.

The invention is also described using flowchart illustrations and blockdiagrams. It will be understood that each block (of the flowcharts andblock diagrams), and combinations of blocks, can be implemented bycomputer program instructions. These program instructions may beprovided to a processor circuit, such as a microprocessor,microcontroller or other processor, such that the instructions whichexecute on the processor(s) create means for implementing the functionsspecified in the block or blocks. The computer program instructions maybe executed by the processor(s) to cause a series of operational stepsto be performed by the processor(s) to produce a computer implementedprocess such that the instructions which execute on the processor(s)provide steps for implementing the functions specified in the block orblocks.

Accordingly, the blocks support combinations of means for performing thespecified functions, combinations of steps for performing the specifiedfunctions and program instruction means for performing the specifiedfunctions. It will also be understood that each block, and combinationsof blocks, can be implemented by special purpose hardware-based systemswhich perform the specified functions or steps, or combinations ofspecial purpose hardware and computer instructions.

FIGS. 1 and 2 are block diagrams of electrical stimulation devices 100formed in accordance with embodiments of the invention. Someconventional components are not shown in order to simplify theillustrations, such as a battery used to power the circuitry of thedevice 100, communications circuitry configured to receive and/ortransmit data to a programmer located externally to the patient, andother conventional implantable stimulator components.

In one embodiment, the device 100 includes a control unit 101 thatincludes a hermetically sealed housing that protects the circuitry ofthe control unit 101 when the device 100 is implanted within a patient.In one embodiment, the circuitry includes a controller 102, memory 104,and one or more pulse generators 106.

The controller 102 includes one or more processors that are configuredto execute program instructions that are stored in the memory 104 and/orcommunicated to the device 100 from an external programmer. Variousfunctions and method steps described herein are performed by the device100 responsive to the execution of the program instructions by the oneor more processors of the controller 102. The programs stored in thememory 104 may be configured prior to implantation of the device 100 inthe patient, or configured or revised after implantation of the device100 using a suitable programmer in accordance with conventionaltechniques.

In one embodiment, at least two electrode leads 110 and 112 are coupledto the control unit 101. The electrode leads 110 and 112 each includeone or more electrodes 114. Electrical pulses generated by the one ormore pulse generators 106 can be delivered to a target stimulation siteof the patient, such as separate target sites 116 and 118, through theelectrodes 114. The electrode leads 110 and 112 may include aconventional tissue anchor, such as a helical coil or other fixationcomponent, that resists migration of the distal ends of the electrodeleads within the tissue of the patient.

In one embodiment, the target sites 116 and 118 are selected based uponthe pelvic condition to be treated. In one embodiment, when theelectrical stimulation therapy is configured to treat urinaryincontinence of a patient, the target site may be the urinary sphincterof the patient, or one or more nerves that innervate the urinarysphincter of the patient. When the pelvic condition to be treated inresponse to the electrical stimulation therapy is fecal incontinence,the target site may be the anal sphincter of the patient, or one or morenerves that innervate the anal sphincter of the patient. When the pelviccondition to be treated by the electrical stimulation therapy is urinaryretention, the target site may be bladder muscles of a patient, whichare relaxed in response to the electrical stimulation therapy. When thepelvic condition of the patient to be treated by the electricalstimulation therapy is pain due to interstitial cystitis, the targetsite may be one or more muscles of the pelvic floor, such as the levatorani. Other target sites within the pelvic region may be selected as thetarget site 116 or 118 in accordance with conventional pelvic conditionstimulation treatments.

In one embodiment, the memory 104 includes at least two stimulationprograms, such as a first stimulation program 120 and a secondstimulation program 122. Electrical stimulation pulses are generated bythe at least one pulse generator 106 in response to the execution ofeach of the stimulation programs 120 and 122 by the one or moreprocessors of the controller 102. In one embodiment, the electricalstimulation pulses generated in response to the execution of the firststimulation program 120 are delivered to the target site 116 through theelectrode lead 110, and the electrical pulses generated in response tothe execution of the second stimulation program 122 are delivered to thetarget site 118 through the electrode lead 112.

In one embodiment, the stimulation pulses generated in response to theexecution of the first stimulation program 120 are configured to treat afirst pelvic condition of the patient, and the stimulation pulsesgenerated in response to the execution of the second stimulation program122 are configured to treat a second pelvic condition that is differentfrom the first pelvic condition. Exemplary embodiments of the first andsecond pelvic conditions include urinary incontinence, fecalincontinence, pain due to interstitial cystitis, urine retention, andother pelvic conditions that are treatable through an electricalstimulation therapy. The electrical stimulation pulses generated by theone or more pulse generators 106 may be in accordance with conventionalstimulation therapies, such as those described in U.S. Pat. Nos.6,652,449, 6,354,991 and 6,896,651, for example.

In one embodiment, the stimulation device 100 includes at least twopulse generators 106, such as pulse generator 106A and pulse generator106B, as shown in FIG. 1. In one embodiment, the pulse generators 106Aand 106B are substantially distinct electrical pulse generator circuitsthat are each configured to generate electrical stimulation pulses fortreating a pelvic condition of a patient responsive to the execution ofa stimulation program stored in memory 104. Each of the pulse generators106A and 106B may be formed in accordance with conventional pulsegenerators.

In one embodiment, the pulse generator 106A generates electricalstimulation pulses in response to the execution of the stimulationprogram 120 by the controller 102. In one embodiment, the device 100 isconfigured to electrically couple the electrode lead 110 to the pulsegenerator 106A, or the electrode lead 110 is electrically coupled to thepulse generator 106A. Accordingly, the electrode lead 110 receives thestimulation pulses generated by the pulse generator 106A. As a result,the electrical stimulation pulses generated by the pulse generator 106Ain response to the execution of the stimulation program 120 aredelivered to the target site 116 through the electrode lead 110 and thecorresponding electrodes 114.

In one embodiment, the pulse generator 106B generates electricalstimulation pulses in response to the execution of the stimulationprogram 122 by the controller 102. In one embodiment, the device 100 isconfigured to electrically couple the electrode lead 112 to the pulsegenerator 106B, or the electrode lead 112 is electrically coupled to thepulse generator 106B. Accordingly, the electrode lead 112 receives thestimulation pulses generated by the pulse generator 106B. As a result,the electrical stimulation pulses generated by the pulse generator 106Bin response to the execution of the stimulation program 122 aredelivered to the target site 118 through the electrode lead 112 and thecorresponding electrodes 114.

In accordance with another embodiment, the device 100 includes a singlepulse generator 106 and a switch 124, as illustrated in FIG. 2. Inaccordance with this embodiment, electrical stimulation pulses aregenerated by the pulse generator 106 and delivered to the switch 124,which directs the stimulation pulses to either the electrode lead 110implanted at the stimulation site 116, or the electrode lead 112implanted at the stimulation site 118.

The switch 124 can be any suitable electrical component or circuitconfigured to perform the desired switching function, and may comprisesemiconductor transistors and other conventional components. In oneembodiment, the switch 124 has a first state, in which the electrodelead 110 is electrically coupled to the pulse generator 106 and, thus,is configured to receive the stimulation pulses generated by the pulsegenerator 106. While the switch is in the first state, the electrodelead 112 is electrically disconnected from the pulse generator 106. Thatis, stimulation pulses generated by the pulse generator 106 are notdelivered directly to the electrode lead 112 through the switch 124.

In one embodiment, the switch 124 has a second state, in which theelectrode lead 112 is electrically coupled to the pulse generator 106and, thus, is configured to receive electrical stimulation pulsesgenerated by the pulse generator 106. While the switch is in the secondstate, the electrode lead 110 is electrically disconnected from thepulse generator 106. That is, stimulation pulses generated by the pulsegenerator 106 are not delivered directly to the electrode lead 110through the switch 124.

In one embodiment, the controller 102 is configured to set the switch124 in either the first or second state depending upon the stimulationprogram being executed. In one embodiment, the controller 102 sets theswitch in the first state in response to, or in preparation of, theexecution of the stimulation program 120, and sets the switch 124 in thesecond state in response to, or in preparation of, the execution of thestimulation program 122. As a result, electrical stimulation pulses thatare generated by the pulse generator 106 in response to the execution ofthe stimulation program 120 are delivered to the target site 116 throughthe switch 124, the electrode lead 110 and its corresponding electrodes114. Likewise, electrical stimulation pulses generated by the pulsegenerator 106 in response to the execution of the stimulation program122 are delivered to the target site 118 through the switch 124, theelectrode lead 112 and the corresponding electrodes 114.

Another embodiment of the invention is directed to a method of treatingmultiple pelvic conditions of a patient using the stimulator device 100formed in accordance with the embodiments described above with regard toFIGS. 1 and 2. FIG. 3 is a flowchart illustrating the method inaccordance with embodiments of the invention.

At 130 of the method, the stimulation device 100 comprising a controlunit 101 and first and second electrode leads 110 and 112 are implantedin a patient. In one embodiment, the device 100 is implanted in thepelvic region of a patient. In one embodiment, the electrodes 114 of theelectrode lead 110 are implanted in a target site 116 of the patient,and the electrodes 114 of the electrode lead 112 are implanted in atarget site 118 of the patient that is different from the target site116, as described above.

At 132 of the method, a first stimulation treatment is performed throughthe first electrode lead 110. When the device 100 is formed inaccordance with the embodiment described above with regard to FIG. 1,step 132 involves generating electrical stimulation pulses using thepulse generator 106A in response to the execution of the stimulationprogram 120 by the one or more processors of the controller 102. Thestimulation pulses generated by the pulse generator 106A are deliveredto the target site 116 through the electrode lead 110.

In accordance with another embodiment, step 132 is performed using thedevice 100 described above with reference to FIG. 2. In accordance withthis embodiment, electrical pulses are generated by the pulse generator106 in response to the execution of the stimulation program 120 by theone or more processors of the controller 102. The controller 102 alsosets the switch 124 in the first state to electrically couple the pulsegenerator 106 to the electrode lead 110. The stimulation pulsesgenerated by the pulse generator 106 are delivered to the target site116 through the switch 124 and the electrode lead 110 to perform thefirst stimulation treatment.

At 134, a first pelvic condition is treated in response to the firststimulation treatment. The first pelvic condition treated in step 134may be any of those described above.

At 136 of the method, a second stimulation treatment is performedthrough the second electrode lead 112. When the device 100 is formed inaccordance with the embodiments described above with reference to FIG.1, step 136 involves generating electrical stimulation pulses using thepulse generator 106B in response to the execution of the stimulationprogram 122 by the one or more processors of the controller 102. Thestimulation pulses generated by the pulse generator 106B are deliveredto the elect target site 118 through the electrode lead 112 and thecorresponding electrodes 114.

When the device 100 is formed in accordance with the embodimentsdescribed above with regard to FIG. 2, step 136 involves generatingelectrical stimulation pulses using the pulse generator 106 in responseto the execution of the stimulation program 122 by the one or moreprocessors of the controller 102. In one embodiment, the controller 102sets the switch 124 in the second state such that the stimulation pulsesgenerated by the pulse generator 106 are delivered to the target site118 through the switch 124 and the electrode lead 112.

At 138 of the method, a second pelvic condition of a patient is treatedin response to the second stimulation treatment. The second pelviccondition may be selected from any of those described above.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. For example, the device 100 may include morethan two pulse generators, each configured to deliver stimulation pulsesto a separate electrode lead.

1-15. (canceled)
 16. Implantable electrical stimulation device fortreating one or more pelvic conditions comprising: an implantablecontrol unit comprising: memory; at least two stimulation programsstored in the memory; a controller comprising at least one processorconfigured to execute at least two stimulation programs stored in thememory; and at least one pulse generator; and first and second electrodeleads coupled to the control unit, the first and second leads eachcomprising one or more electrodes; wherein electrical stimulation pulsesgenerated by the at least one pulse generator are delivered to the firstand second electrode leads in response to the execution of the at leasttwo stimulation programs.
 17. The device according to claim 16, wherein:electrical stimulation pulses generated by the at least one pulsegenerator in response to the execution of a first stimulation program ofthe at least two stimulation programs are delivered to the firstelectrode lead; and electrical stimulation pulses generated by the atleast one pulse generator in response to the execution of a secondstimulation program of the at least two stimulation programs aredelivered to the second electrode lead.
 18. The device according toclaim 17, wherein: the stimulation pulses generated by the pulsegenerator in response to the execution of the first stimulation programare configured to treat a first pelvic condition; and the stimulationpulses produced by the pulse generator in response to the execution ofthe second stimulation program are configured to treat a second pelviccondition that is different from the first pelvic condition.
 19. Thedevice according to claim 18, wherein the first and second pelvicconditions are selected from the group consisting of urinaryincontinence, fecal incontinence, pain due to interstitial cystitis andurine retention.
 20. The device according to claim 19, wherein the atleast one pulse generator comprises first and second pulse generators,the first pulse generator produces electrical stimulation pulses inresponse to the execution of the first stimulation program, and thesecond pulse generator produces electrical stimulation pulses inresponse to the execution of the second stimulation program.
 21. Thedevice according to claim 16, further comprising a switch having a firststate in which the first electrode lead is electrically coupled to theat least one pulse generator, and a second state in which the secondelectrode lead is electrically coupled to the at least one pulsegenerator, wherein the controller controls the state of the switch. 22.The device according to claim 21, wherein: the controller sets theswitch in the first state and electrical stimulation pulses generated bythe pulse generator are delivered to the first electrode lead responsiveto the execution of a first stimulation program of the at least twostimulation programs; and the controller sets the switch in the secondstate and electrical stimulation pulses generated by the pulse generatorare delivered to the second electrode lead responsive to the executionof a second stimulation program of the at least two stimulationprograms.
 23. The device of claim 22, wherein: the stimulation pulsesgenerated by the pulse generator in response to the execution of thefirst stimulation program are configured to treat a first pelviccondition; and the stimulation pulses produced by the pulse generator inresponse to the execution of the second stimulation program areconfigured to treat a second pelvic condition that is different from thefirst pelvic condition.
 24. The device according to claim 23, whereinthe first and second pelvic conditions are selected from the groupconsisting of urinary incontinence, fecal incontinence, pain due tointerstitial cystitis and urine retention.
 25. A method of treating atleast one pelvic conditions of a patient comprising: implanting anelectrical stimulation device in a patient, the electrical stimulationdevice comprising a control unit, memory, at least one pulse generator,a first electrode lead, and a second electrode lead; deliveringelectrical stimulation pulses from the at least one pulse generatorthrough the first electrode lead in response to executing a firststimulation program stored in the memory using at least one processor ofthe control unit; delivering electrical stimulation pulses from the atleast one pulse generator through the second electrode lead in responseto executing a second stimulation program stored in the memory using theat least one processor of the control unit; treating at least one pelviccondition in response to the delivery of electrical stimulation pulsesthrough the first and second electrode leads.
 26. The method accordingto claim 25, wherein treating at least one pelvic condition comprisestreating a first pelvic condition in response to the delivery ofelectrical stimulation pulses through the first electrode lead.
 27. Themethod according to claim 26, wherein the first pelvic condition isselected from the group consisting of urinary incontinence, fecalincontinence, pain due to interstitial cystitis and urine retention. 28.The method according to claim 26, wherein treating at least one pelviccondition comprises treating a second pelvic condition in response tothe delivery of electrical stimulation pulses through the secondelectrode lead.
 29. The method according to claim 28, wherein the secondpelvic condition is different than the first pelvic condition.
 30. Themethod according to claim 29, wherein the first and second pelvicconditions are selected from the group consisting of urinaryincontinence, fecal incontinence, pain due to interstitial cystitis andurine retention.
 31. The method according to claim 30, whereinimplanting an electrical stimulation device in a patient comprises:implanting one or more electrodes of the first electrode lead at a firststimulation site; and implanting one or more electrodes of the secondelectrode lead at a second stimulation site that is different from thefirst stimulation site.
 32. The method according to claim 31, whereinthe first and second stimulation sites are selected from the groupconsisting of the urinary sphincter of the patient and the analsphincter of the patient.